Air-way puncture device



Jan. 15, 1957 J. G. THOMAS ET AL AIR-WAY PUNCTURE DEVICE Filed March 29,1955 IN V EN TORS.

United `l atent James G. Thomas, Skokie, and Cyrus R. Broman, Evanston,Ill., assignors to Baxter Laboratories, Inc. i Application March 29,1955, Serial No. 497,574

6 Claims. (Cl. 12S-214) This invention relates to an air-waypuncturedevice for luse in conjunction with a parenteral solutionconsupplied yas the contents under a pressure less than atmospheric. Tov preserve this vacuum condition it is necessary thatthe glasscontainers be securely capped, and it has been the uniform practice toprovide a rubber stopper mounted in the container mouth and securedagainst inward or outward movement. The stopper, being of considerablethickness, is provided with passageways extending therethrough to permitthe discharge of the contents of the container and to permit entry ofreplacement air for the discharged contents. These passageways areclosed prior to actual administration by means of thin, puncturablediaphragms which are provided as integral parts of the stopper.

Our invention relates to a device for puncturing the diaphragm extendingacross one of the passages in the stopper mounted in a parenteralsolution container. The passage to which the puncture device `of ourinvention is to be applied is known as the air-way passage since itpermits air to enter the container, normally through aninwardly-extending glass air tube, to re- ICC 2 the accompanying drawingin which Fig. 1 is a perspective view of a conventional parenteraladministration system and which is equipped with the puncture device ofour invention; Fig. 2 is an enlarged cross-secytional view of the deviceof our invention in the form in which it is used as a protector for theplug-in portion of a parenteral administration set; and Fig. 3, is aperspective view of the device of our4 invention in the form in which itis used as a puncturing device. v

Referring now to the drawing and, in particular, Fig. l, the numeral 10indicates a parenteral solution bottle which is suspended in amouth-downward condition by means of bail 11 from suitable support means(not shown). Mounted in the downwardly facing mouth .of container 10 isstopper 12.

Inserted into one of the passageways that extend through stopper 12 isthe plug-in portion 13 of parenteral administration set generallydesignated 14. Parenteral administration set 11i includes a length offlexible tubing 15. Aixed to one end of tubing 15 is the previouslyvmentioned plug-in 13, and aflixed to the other end is hypodermic needle16. in the usual administration set, means for determining the rate ofow is generally employed in the form of a drip tube 15a, which permitsthe nurse 4or doctor supervisingthe administration to count the numberof drops falling therethrough. The rate of flow is generally regulatedby some form of clamping means, such as the clamp designated 17.

Inserted into the other passageway of stopper 12 is the air-way puncturedevice of our invention, generally designated 18. Inserted intothe otherend of the stopper passageway .connected to the puncture device of placethe liquid as it is being discharged through another passageway. Theliquid being discharged through the second-mentioned passageway isconducted to the site of administration, generally by means of anadministration set which includes connectors attached to the ends of alength of flexible tubing. One of these connectors is inserted into thedischarge passage of the stopper and the other connector, generally inthe form of a hypodermic needle, is inserted into the vein of anintended recipient of the solution.

Puncture devices for the diaphragm extending across an air-way passagehave been known to the art, but heretofore none has been able to achievethe advantages present in our device; namely, inexpensiveness ofmanufacture, foolproof usage, and the important function of serving asan integral part of a parenteral administration set up to the time it isused.

Since the keynote in parenteral therapy is maintenance of sterility ofall parts of the system, the parenteral administration set itself ismaintained in a sterile condition by insulating from contact with theatmosphere all surfaces that might contaminate the parenteral solution.In the case of the connectors, this is achieved by incasing them inplastic sleeves which are removed just prior to connection of the setwith the parenteral solution container and the patient.

Essentially, our air-way puncture device includes a plastic sleevehaving a needle mounted axially therein, the sleeve being mounted overthe stopper plug-in portion of a parenteral administration set until itis to be used in its diaphragm-puncturing operation.

Our invention will be explained in conjunction with our invention is airtube 19, which extends inwardly into solution containerltl.

Air-way puncture device 18 in the form in which it is seen in Fig. l canbe better appreciated by examination of Fig. 3, wherein anenlargedperspective view is shown. In Fig. 3y the device is seen to include athermoplastic sleeve 20, and mounted axially in sleeve 20 is needle 21.We prefer that the mounting of needle 21 in sleeve 20 be achieved byfusing, as by heat sealing, opposing wall portions of sleeve 20 asdesignated at 22 to anchor needle 21 therein. Enlarged needle shankportion 21a also cooperates in this anchoring, especially during thepuncturing operation. It is to be noted that the fused portions 22 donot completely block off the axial opening in sleeve 20, so that it ispossible for air to enter the end of sleeve 20 adjacent the sharpenedend of needle 21 in order to ultimately enter container 10. The air flowis indicated by a wavy arrow, and designated 23. The tortuous passagethrough which air iiows and which is achieved by the cooperation offused portions 22 and needle 21, serves as a iilter.y The end 20a ofsleeve 20 opposite the sharpened end of needle 21 is closed, as byfusing through heat-sealing.

The puncture device of our invention is intended to be provided as partof a parenteral administration set, wherein it performs a secondfunction as a protector. This can be appreciated from a consideration ofFig. 2, wherein sleeve 20 is mounted over plug-in 13 of parenteraladministration set 14. In order to facilitate removal of sleeve 20 fromplug-in 13, integral tab 24 is provided. Tab 24 may also be securedseparately to sleeve 20, in which case it should also be providedadjacent the open end of sleeve 20. When sleeve 20 is mounted on plug-in13, as shown in Fig. 2, the sharpened end of needle 21 extends intoplug-in 13, which is provided with a longitudinal passage 13a for theconduction of parenteral solutions.

Thus, it is to be noted that there is no danger of accidental injury byproviding a puncture device having an exposed, sharp needle. Further,al1 the elements which are to be in contact with theparenteral solutionduring administration are insulated from contact with the air up to thetime that they are to be used. From Fig. 2 it can beappreoiated that'thesharpened point of needle A21 is kept 'sharp until use, Asince plug-in'15 facts as fa protector.

Operation lWhen a parenteral solution lis about to beadministeredth'rough an 'administration set provided with the air-waypuncture device of our invention, the l-se`t is removed "from itsshipping 'container and tab 24 is grasped between the thumb andforenger. When 'plugin '133islhel`d'in the other-hand and Atab 24'movedaway `from the hand graspingplug-in 13, sleeve 20rollslba'ck onitselfsubstantially as shown at 25 'in Fig. '3. The double thickness ofsleeve provided thereby serves as a convenient linger graspfor'insertingneedle 21 `through stopper 12, as shown in Fig. A1.

Although the pictured embodiment of our invention shows the end 20c! ofsleeve 20 opposite thesharpene'd end of needle A2l to be closed, wherebya tortu'ousair passage is achieved'through the cooperation of fusingsleeve 20 as at 22, it is to be noted that the air-way puncture device`18 of our invention can havethe above-mentioned end 20a provided inv anopen condition either-during its use as a puncture device or as aprotector, or both. Should it be'desired to be used with an open end 'asa puncture device, it is only necessary for the nurse or doctorsupervising the administration to snip off Athe sealed end portion 2da.Should sleeve 20 be desired to be used'in the form having anopenend-Zawhen in use as aprotector, as shown in Fig. 2, it is onlynecessary to insert a plug of cotton into the open end 20a of sleeve 20.The cotton closing off the end 20aof -sleeve 20 during storage will thenserve as a lter when device 18 is used as an air-way puncture device.

The foregoing detailed description has been given for 'clearness ofunderstanding only, and 'no `unnecessary limitationsshould be inferredtherefrom.

We claim:

l. A puncture devicefor the air passage diaphragm in a stopper closingthe mouth of a parenteral administration container comprising athermoplastic sleevelhaving a needle'permanently anchored naxiallytherein'and means 'closing the end of said sleeve opposite the sharpenedlend 'of said needle, said sleeve being adaptedttoibe removably mountedon the plugin portion of a parenteral administration set to protect saidrplug-in portion against contamination during storage.

2. In combination, an air-way puncture device cornprising athermoplastic sleeve having a needle mounted axially therein; and aparenteral administration set comprising a length of iiexible 'tubingprovided at one end with discharge means and at the other end with astopper plug-in, said sleeve being removably mounted on said plug-inwith the sharpened end of said needle extending inwardly of saidplug-in.

3. The combination of claim 2 wherein the said thern moplastic sleeve isprovided with an integral finger tab extending from the end adjacentthesharpened end of said axially mounted needle.

4. ln combination, an air-way puncture device cornprising athermoplastic sleeve having a needle mounted axially therein by fusingtogether opposite wall :portions of said sleeve; and a parenteraladministration set comprising a length of exible tubing provided at oneend f with discharge means and at the other end with a stopper plug-in,said sleeve being removably mounted on said plug-in.

5. 'Ihecombination of claim 4, wherein the said fused portions are soarranged as to provide spaced, longitudi nal airpassages in said sleeveand the end of said sleeve opposite the sharpened end of said needle isclosed, whereby a-tortuous air passage is provided.

6. In combination, an air-way puncture device compris'ing athermoplastic sleeve having a needle mounted axially therein by spacedfusing of'opposite wall portions of said sleeve whereby a longitudinalpassage is provided in said sleeve external to said needle, said sleevebeing closed at the end opposite the sharpened end of said needle; and aparenteral administration set comprising a length of exible tubingprovided at one end with discharge meansand at the other end with astopper plug-in provided with a longitudinal.liquid-conducting passageextending therethrough, said sleeve being removably mountedon saidplug-in with the sharpened end of said needle extending into thelongitudinal passage of said plug-in.

lReferences Cited in the le of this patent UNITED STATES PATENTS2,725,055 Gewecke Nov. 29, 1955

